Fiasp Vials

What is Fiasp (insulin aspart)?

Fiasp (insulin aspart) is an FDA-approved, man-made (human insulin analog) rapid-acting insulin used to control high blood sugar in patients with type 1 and type 2 diabetes mellitus. Its fast action is enhanced by the addition of Vitamin B3 (niacinamide) and L-arginine, which promote rapid absorption and stability, allowing it to begin working immediately after injection.

How does Fiasp work?

Insulin, including insulin aspart, exert their action by binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating the cellular uptake of glucose into skeletal muscle and adipose tissue and inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Dosage and How to Use

Fiasp is available as an injection in the following dosages and forms

• 100 units/ml (U-100)
• 10 ml multiple dose vial
• 3 ml single-patient-use Fiasp FlexTouch pen

General dosing information

• Fiasp dosages should be based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
• Dose adjustments may be needed when switching from another insulin, changes in physical activity, changes in medications, changes in meal patterns, and other factors.

Important administration information

• Always check the insulin label before administration
• Visually inspect for particulates or discoloration. Only use Fiasp if it is clear and colorless
• Do not ever administer Fiasp intramuscularly
• Do not dilute or mix Fiasp with any other insulin products or solutions, except infusion fluids
• Always use a new needle for each injection

Subcutaneous injection

• Inject Fiasp at or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, or thigh.
• Rotate injection sites within the same region at each injection to reduce the risk of lipodystrophy
• Fiasp given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin
• Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor their blood glucose level to decide if an insulin dose is needed and to resume their usual dosing schedule at the next meal

Storage

 Fiasp vials

• Unused Fiasp vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment.
• Fiasp should not be drawn into a syringe and stored for later use. Only use the product if it has a clear and almost colorless appearance.

Fiasp FlexTouch Pens

• Always remove the needle after injection and store FlexTouch pens without a needle attached.

Storage conditions for vials and Fiasp FlexTouch pens are summarized below:

Fiasp should not be exposed to excessive heat or light and must never be frozen. Do not use Fiasp if it has been frozen.

Keep the cap on the pen to protect Fiasp from light. Keep unused vials and Fiasp FlexTouch in the carton so they will stay clean and protected from light.

Overdose

Mild overdose of insulin can result in hypoglycemia and hypokalemia. Mild hypoglycemia can be treated with oral glucose. If you have severely overdosed your insulin, seek medical attention immediately, as more severe episodes of hypoglycemia can lead to coma, seizures, or neurological impairment. Severe hypoglycemia can be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Hypokalemia must be corrected appropriately.

Side Effects

 Some common side effects with Fiasp are:

• Skin problems such as eczema, itching, and redness
• Reactions at the injection site such as itching and rash
• Skin thickening or pits at the injection site (lipodystrophy)
• Weight gain

Serious side effects that are possible with Fiasp are:

• Hypoglycemia
  • Signs of hypoglycemia may include:
    • Light-headedness
    • Dizziness
    • Confusion
    • Blurred vision
    • Shakiness
    • Anxiety or mood changes
    • Hunger
• Hypokalemia
• Serious allergic reactions
  • Seek medical attention immediately if you have any one of the following signs of a severe allergic reaction:
    • Rash over your whole body
    • Trouble breathing
    • Fast heartbeat
    • Swelling of your face, tongue, or throat
    • Sweating
    • Extreme drowsiness
• Heart failure
  • Taking certain diabetes medications called TZDs (thiazolidinediones) with Fiasp may cause heart failure in some people

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Never Share a Fiasp FlexTouch Pen Between Patients

• FlexTouch pens should never be shared, even if the needle is changed. Sharing poses a risk for the transmission of blood-borne pathogens.

Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

• Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control.

Hypoglycemia

• Hypoglycemia is the most common adverse reaction of all insulin therapies. Severe hypoglycemia can lead to seizures, unconsciousness, and even death. Patients at higher risk for hypoglycemia or who have reduced symptomatic awareness of hypoglycemia may need to monitor blood glucose more frequently.

Hypoglycemia Due to Medication Errors

• Accidental mix-ups between insulin products have been reported. Instruct patients to always check the insulin label before each injection to minimize medication errors.

Hypokalemia

• All insulin products can cause a shift of potassium from the extracellular space to the intracellular space, potentially leading to hypokalemia.

Hypersensitivity and Allergic Reactions

• Severe, life-threatening, generalized allergies, including anaphylaxis, can occur with insulin products.

Fluid Retention and Heart Failure with Concomitant Use of PPAR-Gamma Agonists

• Thiazolidinediones (TZDs) are peroxisome proliferator-activated receptor (PPAR)­ gamma agonists and can cause fluid retention, particularly when used in combination with insulin. Fluid retention can lead to heart failure or exacerbate existing heart failure.

Drug Interactions and Other Interactions

 Drugs That May Increase the Risk of Hypoglycemia

• Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics

Drugs That May Decrease the Blood Glucose Lowering Effect of Fiasp

• Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Fiasp

• Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia

Drugs That May Blunt Signs and Symptoms of Hypoglycemia

• Beta-blockers, clonidine, guanethidine, and reserpine

Contraindications

 Fiasp is contraindicated in any of the following:

• During episodes of hypoglycemia
• In patients with known hypersensitivity to insulin aspart or one of the excipients in Fiasp

Frequently Asked Questions

Disclaimer

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